EMA Notice: European Medicines Agency’s Data Protection Notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme

The European regulatory framework continues to strengthen data protection and transparency in its international collaborations, particularly when engaging with EU candidate countries. As part of this effort, the European Medicines Agency (EMA) has established clear guidelines on how personal data is processed within cooperation programmes.

The guidance European Medicines Agency’s Data Protection Notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme was published on 2 April 2026, outlining how personal data is collected, processed, and protected in the context of the IPA programme.

Introduction

This data protection notice explains how the European Medicines Agency processes personal data in relation to the Instrument for Pre-accession Assistance (IPA) programme, which supports cooperation with EU candidate countries. The guidance ensures that individuals participating in EMA activities are informed about how their personal data is handled, in line with EU data protection regulations.

Background

The IPA programme is a European Commission-funded initiative designed to support EU candidate countries in aligning with EU regulatory frameworks, including medicines regulation. Through this programme, EMA collaborates with countries such as Albania, Serbia, Türkiye, and others to facilitate their participation in regulatory activities, training, and knowledge exchange. This cooperation requires the processing of personal data, making data protection an essential component of programme implementation.

Scope

This guidance applies to the processing of personal data of individuals participating in EMA working groups, meetings, and training activities under the IPA programme. It covers data collected during participation, communication, travel arrangements, reimbursements, and administrative processes associated with EMA’s collaboration with EU candidate countries.

Purpose of Data Processing

The primary purpose of processing personal data is to support the implementation of the IPA programme and enable participation of EU candidate countries in EMA activities. This includes facilitating access to working groups, organising training sessions, supporting meetings, and enabling collaboration between EMA and participating countries. The processing ensures smooth coordination of programme activities and effective knowledge sharing.

Personal data processed under this programme includes identification, contact, and administrative information necessary for participation. This includes names, email addresses, institutional affiliations, travel and accommodation details, reimbursement-related financial information, and declarations of interest. These data elements are essential for organising events, managing participation, and ensuring compliance with regulatory requirements.

Data Transfer Outside the EU

Personal data may be shared with EU candidate countries when participants attend meetings or training sessions. Such transfers are considered necessary for important public interest reasons, particularly in the absence of adequacy decisions or specific safeguards.

Personal data is generally retained for a period of three years, while financial data related to reimbursements is retained for five years in accordance with legal and financial requirements. These retention periods ensure compliance while limiting unnecessary data storage.

References

For complete official guidance, refer to: European Medicines Agency’s Data Protection Notice for the implementation of the Instrument for Pre-accession Assistance (IPA) programme – EMA